Comparison of Therapy in Treatment of Patients With Helicobacter Pylori Infection: Concomitant Versus Hybrid Therapy.
NCT ID: NCT03572777
Last Updated: 2021-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
159 participants
INTERVENTIONAL
2018-04-15
2019-10-15
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The hypothesis of our research is that the two therapeutic options (hybrid and concomitant therapy) will be equally successful in the treatment of Helicobacter pylori infection. In other words, in both therapeutic groups we expect successful treatment of Helicobacter pylori infection in or more than 90 % of patients.
In other studies, both therapeutic options have the same efficacy in treating H. pylori infection. On the other had there are no studies available in Croatia to compare the effectiveness of these therapeutic options so far, which is the main objective of our research. The secondary goals of our study will be: the existence of differences in the occurrence of possible side effects, as well as the compliance between patients in both therapeutic options. It is also our aim to compare the quality of life of patients with Helicobacter pylori infection before and after treatment, via a questionnaire that is common for this purpose.
The study is expected to include a total of 120 patients (60 patients in each therapy group), and the planned duration is 12 months.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Quadruple vs Tailored Therapy in the Treatment of Helicobacter Pylori Infection
NCT04621487
Concomitant Versus Hybrid Regimen for H. Pylori Eradication
NCT03592069
H. Pylori Screen-and-treat Study in a Population of Young Adults
NCT06275204
Comparing the Efficacy of Hybrid, High-dose Dual and Bismuth Quadruple Therapies
NCT03779074
Therapeutic Trial Comparing Triple Therapy Guided by the PCR Detection of Clarithromycin Resistance vs Empiric Concomitant Quadruple Therapy for Helicobacter Pylori Infection
NCT02576236
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Concomitant therapy
Amoxicillin ('Amoksicilin') 1 g bid, metronidazole ('Medazol')500 mg bid, clarithromycin ('Makcin')500 mg bid and esomeprazole ('Emanera')40 mg bid for 14 days.
Concomitant therapy
Amoxicillin ('Amoksicilin') 1 g bid 14 days.
Concomitant therapy
Clarithromycin ('Makcin') 500 mg bid for 14 days
Concomitant therapy
Metronidazole ('Medazol') 500 mg bid for 14 days
Concomitant therapy
Esomeprazole ('Emanera') 40 mg bid for 14 days
Hybrid therapy
Amoxicillin ('Amoksicilin') 1 g bid and esomeprazole ('Emanera') 40 mg bid for 14 days, with metronidazole ('Medazol')500 bid and clarithromycin ('Makcin') 500 mg bid for the last 7 days.
Hybrid therapy
Amoxicillin ('Amoksicilin') 1 g bid 14 days
Hybrid therapy
Esomeprazole ('Emanera') 40 mg bid for 14 days
Hybrid therapy
Clarithromycin ('Makcin') 500 mg bid for the last 7 days
Hybrid therapy
Metronidazole ('Medazol') 500 mg bid for the last 7 days
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Concomitant therapy
Amoxicillin ('Amoksicilin') 1 g bid 14 days.
Concomitant therapy
Clarithromycin ('Makcin') 500 mg bid for 14 days
Concomitant therapy
Metronidazole ('Medazol') 500 mg bid for 14 days
Concomitant therapy
Esomeprazole ('Emanera') 40 mg bid for 14 days
Hybrid therapy
Amoxicillin ('Amoksicilin') 1 g bid 14 days
Hybrid therapy
Esomeprazole ('Emanera') 40 mg bid for 14 days
Hybrid therapy
Clarithromycin ('Makcin') 500 mg bid for the last 7 days
Hybrid therapy
Metronidazole ('Medazol') 500 mg bid for the last 7 days
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* written informed consent
Exclusion Criteria
* previously treatment of Helicobacter pylori infection
* malignancy of stomach or other site
* history of taking proton pump inhibitors, H2 antagonist, bismuth or antibiotics (amoxicillin, metronidazole, clarithromycin) in previous month
* significant underlying disease (renal failure, psychiatric disorders)
* history of allergic reactions to any medications used in study
* refuse to participate in study
* breastfeeding and pregnancy
* quitting the study
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University Hospital of Split
OTHER
University of Split, School of Medicine
OTHER
Antonio Mestrovic
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Antonio Mestrovic
Sponsor-Investigator
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Antonio Meštrović, MD
Role: PRINCIPAL_INVESTIGATOR
University Hospital Centre Split, Croatia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital Centre Split
Split, , Croatia
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Mestrovic A, Perkovic N, Bozic J, Pavicic Ivelja M, Vukovic J, Kardum G, Puljiz Z, Tonkic A. Randomised clinical trial comparing concomitant and hybrid therapy for eradication of Helicobacter pylori infection. PLoS One. 2020 Dec 30;15(12):e0244500. doi: 10.1371/journal.pone.0244500. eCollection 2020.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
003-08/18-03/0001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.